COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Krenosin» (18A02236)
Estratto determina AAM/PPA n. 205 del 2 marzo 2018 Autorizzazione delle variazioni. Variazioni di tipo II: B.II.d.1.e), B.II.d.1.z), e variazioni di tipo IB: B.II.d.2.d), B.II.d.1.z), relativamente al medicinale KRENOSIN. Codice pratica: VN2/2017/282. Sono autorizzate le seguenti variazioni: Variazione B.II.d.1.e di tipo II: Allargamento dei limiti di accettabilita' della specifica «pH» al rilascio del prodotto finito: Parte di provvedimento in formato grafico Variazione B.II.d.1.z di tipo II: Aggiornamento delle specifiche dei prodotti di degradazione con il corrispondente nuovo metodo HPLC al rilascio e al termine del periodo di validita': Parte di provvedimento in formato grafico Variazione B.II.d.2.d di tipo IB: Altre modifiche di una procedura di prova (sostituzione): identificazione del principio attivo mediante UV (invece di TLC) al rilascio;
Variazione B.II.d.2.d di tipo IB: Altre modifiche di una procedura di prova (sostituzione): identificazione del principio attivo mediante nuovo metodo LC (invece del precedente metodo LC) al rilascio e al termine del periodo di validita';
Variazione B.II.d.2.d di tipo IB: Altre modifiche di una procedura di prova (sostituzione): dosaggio del principio attivo mediante nuovo metodo LC (invece del precedente metodo LC) al rilascio e al termine del periodo di validita': Parte di provvedimento in formato grafico Variazione B.II.d.1.z di tipo IB: Eliminazione di un parametro di specifica non significativo (eliminazione del contenuto di NaCl al rilascio): Parte di provvedimento in formato grafico relativamente al medicinale «Krenosin», nella forma e confezione: A.I.C. n. 028990012 - «6 mg/2 ml soluzione iniettabile per uso endovenoso» 6 flaconcini 2 ml...
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